Senior Clinical Research Associate (level dependent on experience)

Senior Clinical Research Associate (level dependent on experience)Job CategoryClinical MonitoringRequisition NumberSENIO002087Posted : October 12, 2026Full-TimeRemoteLocationsShowing 1 locationUnited States - RemoteDescriptionWhat you'll do:Serve as the main CTI contact for assigned study sitesConduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in the Monitoring Plan while adhering to all applicable regulatory requirements, SOPs, and ICH GCPAssist with study start-up activities, including feasibility, pre-study activities, and site selectionCollect, review, and track essential/regulatory documentsParticipate in and complete all general and study-specific training as requiredParticipate in investigator, client, and project team meetingsCreate and implement subject enrollment strategies for assigned study sitesEnsure proper storage, dispensation, and accountability of all Investigational Product (IP) and trial-related materialsPerform site management activities and provide ongoing updates of site status to the Clinical Project ManagerConduct remote monitoring and complete the related activities in accordance with study study-specific Monitoring PlanUtilize systems and reports to track subject status, subject case report form (CRF) retrieval/source document review (SDV), regulatory documents, and IPAssist with project-specific activities as a member of the Project TeamMay support in the development of CRFs and other study-related documents (subject worksheets, Monitoring Plan, etc.)May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis, and other study-applicable documents as per required proceduresWhere applicable, provide support to the Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions' Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow up on the evaluation process until approval is available. Provide regular updates to the Sponsor/ ClientAssist in preparing and coordinating Investigator and client meetings, and attend meetings as necessaryLiaise with Clinical Data Management for data cleaning activitiesIdentify site issues and implement corrective actions or escalation as appropriateManage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring PlansWhere applicable, support in contract negotiation with study sites, Investigator payments, and tracking of site paymentsWhat You'll Bring:At least 1 year of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human ResourcesBachelor's Degree or higher in an allied health field such as nursing, pharmacy, or health / natural science, or RN with an Associate's Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience, or equivalent experience as determined by CTI Management and Human ResourcesPrevious experience in conducting clinical research studies in a hospital setting, a pharmaceutical company, or a CRODemonstrated successful performance in a CRA position with a minimum of 1 year of on-site monitoring experience preferredAbout CTICTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit CTI?Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.Please NoteWe will never communicate directly with you via Microsoft Teams Messaging or by text messageWe will never ask for your bank account information at any point during the recruitment processEqual Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThis employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.Equal Opportunity EmployerThis employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.J-18808-Ljbffr